跳至主要内容
临床试验/NCT04842344
NCT04842344Unknown不适用

A Prospective Randomized Controlled Trial of Extracorporeal Carbon Dioxide Removal (ECCO2R) in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Severe Hypercapnia

Li Xuyan2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
176
试验地点
2
主要终点
Demand rate of endotracheal intubation

研究概览

简要总结

Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Noninvasive ventilation has become the first-line respiratory support for the treatment of AECOPD with hypercapnia and respiratory failure. However, 26-54% of AECOPD patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. For these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. In AECOPD patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood CO2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. As a new type of respiratory support technology, ECCO2R is worthy of attention in monitoring and evaluation of support effect in AECOPD patients with respiratory failure. It is urgent that ECCO2R can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AECOPD patients.
  • The patients with hypercapnia respiratory failure were admitted to ICU and needed noninvasive ventilation.
  • The results of blood gas analysis showed pH <7.30, PaCO2> 50 mmHg.
  • There were high risk factors for failure of noninvasive ventilation: after receiving continuous 2 hours of noninvasive ventilation, the arterial blood pressure showed the pH value was ≤ 7.30, while PaCO2 was 20% higher than the baseline value, and any one or more of the following conditions were combined: respiratory rate ≥ 30 times / min, assisted respiratory muscle breathing; contradictory breathing.
  • Informed consents were sighed.

排除标准

  • The mean arterial pressure was less than 60 mmHg after volume and vasoactive drug treatment.
  • There were anticoagulant contraindications.
  • Weight over 120kg.
  • Patients with malignant tumor or other complications, the expected survival time was less than 30 days.
  • It could not cooperate with noninvasive ventilation or has contraindication of noninvasive ventilation.

结局指标

主要结局

Demand rate of endotracheal intubation

时间窗: 28 days

次要结局

  • Actual rate of endotracheal intubation(28 days)
  • length of ICU stay(28 days)
  • length of hospital stay(28 days)
  • hospital mortality(28 days)

研究者

发起方
Li Xuyan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Li Xuyan

Sponsor Investigator

Beijing Chao Yang Hospital

研究点 (2)

Loading locations...

相似试验

ECCO2R in the Treatment of Acute Exacerbation of... | 临床试验